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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSYNCHRONY,SYNCHRONY II & III SOLUS, SOLUS II & TRIOLOGY PACEMAKERS
Generic Nameimplantable pacemaker Pulse-generator
Regulation Number870.3610
ApplicantABBOTT MEDICAL
15900 Valley View Ct.
Sylmar, CA 91335
PMA NumberP880086
Supplement NumberS035
Date Received03/12/1996
Decision Date10/09/1996
Product Code DXY 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
MODIFICATION TO THE LABELING TO INCLUDE A "CELLULAR TESTED" LOGO TO THE SHELF PACKAGE OF THE FOLLOWING PACEMAKER MODELS: PHOENIX 2 (2005/2008/2009), PARAGON (2010/2011/2012), PARAGON II (2016), SYNCHRONY (2020), SYNCHRONY II (2022/2023), SYNCHRONY III (2028/2029), SOLUS (2002/2003), SOLUS II (2006/2007), TRILOGY (2350/2308/2250) AND REVISION OF THE PATIENT MANUAL TO INCLUDE THE LOGO AND LANGUAGE INFORMING THE PATIENT THAT NO SPECIAL CELL PHONE PRECAUTIONS NEED TO BE TAKEN BY PATIENTS RECEIVING THESE MODELS
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